Entecavir Side Effects

Not all side effects for entecavir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to entecavir: oral solution, oral tablet

In addition to its needed effects, some unwanted effects may be caused by entecavir. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking entecavir:

Incidence not known

Abdominal or stomach discomfort

cough

decreased appetite

diarrhea

difficulty with swallowing

dizziness

fast heartbeat

fast, shallow breathing

general feeling of discomfort

hives, itching, or rash

muscle pain or cramping

nausea

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

right upper abdominal or stomach pain and fullness

sleepiness

tightness in the chest

unusual tiredness or weakness

Some of the side effects that can occur with entecavir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common

Acid or sour stomach

belching

headache

heartburn

indigestion

stomach discomfort, upset, or pain

Rare

Trouble sleeping

Unusual drowsiness

Incidence not known

Hair loss

thinning of the hair

For Healthcare Professionals

Applies to entecavir: oral solution, oral tablet

General

The most common side effects reported in patients with chronic hepatitis B virus (HBV) infection and compensated liver disease during clinical trials have included headache, fatigue, dizziness, and nausea. One percent of patients discontinued therapy due to side effects or laboratory abnormalities (compared to 4% of lamivudine-treated patients).

The most common side effects reported in patients with chronic HBV infection and evidence of hepatic decompensation (n=102) through Week 48 of a study have included peripheral edema, ascites, pyrexia, hepatic encephalopathy, and upper respiratory infection. The cumulative death rate was 23% with entecavir during the first 48 weeks of therapy (compared to 33% with adefovir). The majority of deaths were due to liver-related causes such as hepatic failure, hepatic encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage. Through Week 48, up to 7% of patients discontinued this drug due to a side effect.[Ref]

Elevated ALT (greater than 10 times ULN and greater than 2 times baseline: up to 2%; greater than 5 times ULN: up to 12%; greater than 3 times baseline: up to 5%; greater than 2 times baseline [with total bilirubin greater than 2 times ULN and greater than 2 times baseline]: up to 1%) and total bilirubin (greater than 2.5 times ULN; up to 3%) have been reported.

Posttreatment exacerbations of hepatitis or ALT flare, as defined by ALT greater than 10 times ULN and greater than 2 times baseline, have been reported in patients who discontinued therapy at or after 52 weeks after achieving a defined treatment response (nucleoside-naive HBeAg-positive: 2%; nucleoside-naive HBeAg-negative: 8%; lamivudine-refractory: 12%). The median time to exacerbation was 23 to 24 weeks. The rate may be higher in patients who discontinue this drug without regard to treatment response.

Other

Peripheral edema, ascites, and pyrexia were reported in patients with hepatic decompensation.[Ref]

Oncologic

Very common (10% or more): Hepatocellular carcinoma (up to 12%)Frequency not reported: Malignant neoplasms[Ref]

Hepatocellular carcinoma was reported in patients with hepatic decompensation.

Malignant neoplasms, occurring at a rate of 8.4 per 1000 patient-years, have been reported.[Ref]

Renal

Confirmed creatinine increase of at least 0.5 mg/dL was reported in up to 2% of patients with compensated liver disease. Confirmed increase in serum creatinine of 0.5 mg/dL (11%) and renal failure were reported in patients with hepatic decompensation.[Ref]

Very common (10% or more): Increased serum creatinine (up to 11%)Uncommon (0.1% to 1%): Renal failure[Ref]

Consumer resources

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